Efficacy and safety of Lactiplantibacillus plantarum KF511 for respiratory symptoms: A 12-week randomized, double-blind, placebo-controlled clinical trial

Jeonbuk National University Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月2日

适应症

试验速览

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•1) Aged 19 to 80 years
•2) A person who has two or more symptoms of persistent respiratory symptoms (cough, sputum, dyspnoea or chest pain) for at least one month
•3) Voluntary agreement to participate in the clinical trials and provision of informed consent

•2) Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70% or FVC< 80%
•3) History of underlying chronic respiratroy disease such as COPD or asthma
•4) Clinically significant lung disease findings on chest X-ray (bronchiectasis, cystic fibrosis, bronchiolitis obliterans, active tuberculosis, pneumothorax, emphysema, etc.)
•5) History of acut respiratory infection, and influenza etc. within 4 weeks
•6) Administration of antitussive, apophlegmatic, steroids, and antibiotics etc. within 4 weeks
•7) Intake of probiotics within 2 weeks before screening visit
•8) Allergic or hypersensitivity to drug and any of the ingredients in the test products (probiotics)
•9) History of alcohol or substance abuse
•10) Participation in other clinical trials within 3 months
•11) AST or ALT > 3 fold of normal range or serum creatinine > 2.0 mg/dl
•12) Pregnant, planning to become pregnant, or breast-feeding
•13) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the studya n

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